2023 FDA Pharmaceutical Companies 
STAT
APRIL 4, 2025
The FDA expressed concern, specifically, about in-vitro studies, which are run to test biological processes. The agency identified “significant” problems with data integrity and the way studies were conducted by Raptim Research, which had been hired by the drugmakers to test their medicines.
pharmaphorum
JUNE 12, 2025
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The Checkup by Singlecare
DECEMBER 2, 2024
However, the Food and Drug Administration (FDA) has approved a generic mixture of ipratropium and albuterol —Combivent Respimat’s active ingredients—for use by COPD patients. Generic drugs are often more affordable than their brand-name references, but unfortunately, there are no current generics for Combivent Respimat. Many times, yes.
pharmaphorum
JUNE 20, 2025
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Drug Topics
AUGUST 12, 2025
1 The FDA recommended that the US Drug Enforcement Administration (DEA) move medical marijuana from Schedule I to Schedule III. 2 This determination was based on the FDA’s evaluation of abuse potential, dependency, and accepted medical use for marijuana. August 29, 2023. tetrahydrocannabinol (THC). There are 2 likely tracks.
Pharmacy Times
JUNE 24, 2025
This is progressing through a phase 3 trial and includes comparator arms with standard-of-care treatments like daratumumab, bortezomib (Velcade; Millennium/Takeda and Janssen Pharmaceutical Companies), and lenalidomide. 2 We’re still trying to figure out where these new treatments best fit.
Pharmacy Times
JUNE 23, 2025
The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent. The FDA Approval Process Within the FDA approval process, the 505(b)(1) new drug application (NDA) submission pathway is the pathway by which new drugs are able to seek approval.
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